FDA 483 - Marc R. Bloomenstein, O.D.

An FDA inspection of Marc R. Bloomenstein, O.D., a clinical investigator in Scottsdale, AZ, revealed a significant deficiency in the conduct of a clinical study. The investigation was not performed in accordance with the signed statement of investigator and investigational plan, specifically by enrolling subjects who failed to meet the established eligibility criteria. This indicates a serious deviation from protocol requirements.